Status:
COMPLETED
Assessment of Patterns of Patient Reported Outcomes in Adults With Congenital Heart Disease - International Study II
Lead Sponsor:
KU Leuven
Conditions:
Congenital Heart Disease
Eligibility:
All Genders
18+ years
Brief Summary
This is an international, cross-sectional and descriptive study that aims to investigate differences in patient-reported outcome measures (PROMs) and patient-reported experience measures (PREMs) and t...
Detailed Description
The research aims of this study are: 1. To further explore differences in a modified selection of patient-reported outcome measures (PROMs) and (as a new addition in APPROACH-IS II) explore differenc...
Eligibility Criteria
Inclusion
- Diagnosed with congenital heart disease, defined as: "a gross structural abnormality of the heart and/or intra-thoracic great vessels that is actually or potentially of functional significance (including mild, moderate, and complex heart defects)"
- Aged 18 years of age or older at the moment of study inclusion
- Diagnosed with congenital heart disease before the age of 10 years
- Follow-up at an ACHD center or included in a national/regional registry
- Physical, cognitive, and language abilities to complete self-report questionnaires
Exclusion
- \- Prior heart transplantation
Key Trial Info
Start Date :
August 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
8415 Patients enrolled
Trial Details
Trial ID
NCT04902768
Start Date
August 1 2019
End Date
December 31 2022
Last Update
May 16 2024
Active Locations (53)
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1
University of California
San Francisco, California, United States, 92093-0021
2
Lucile Packard Children's Hospital and Stanford Health Care
Stanford, California, United States, 94304
3
University of Florida Health
Gainesville, Florida, United States, 32611
4
Taussig Heart Center of Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287